Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

NCT07396428 | Recruiting

• 2 other identifiers: Req-2024-00897212429
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The ImpProGUIDE study aims to find out whether implementing new Swiss national guidelines for acute respiratory infections (ARI) can help to reduce antibiotic prescribing in primary care. In Switzerland, most antibiotics are prescribed in outpatient care, and many of these prescriptions may not be needed - especially when infections are caused by viruses, which antibiotics do not treat. Reducing overuse of antibiotics is important to slow the spread of antibiotic resistance. The new guidelines were developed by the Swiss Society for Infectious Diseases (SSI) to support family doctors in managing ARIs, based on a syndromic approach. They recommend the targeted use of point-of-care C-reactive protein (CRP) testing when bacterial infection is suspected, as well as shared decision-making with patients. This study will be carried out in quality circles (QCs) - small groups of family doctors who meet regularly to discuss and improve clinical practice - and in walk-in clinics in French- and Italian-speaking regions of Switzerland. Each will be randomly assigned to either an "intervention" group or a "control" group. In the intervention group, QC moderators and medical center directors will receive implementation resources to lead a session and distribute materials to their group in autumn 2025 on the new guidelines. Doctors can then decide whether or not to use the recommendations in their consultations. In the control group, QCs and centers will continue their regular activities. They will receive access to the same educational materials later, in summer 2026. Throughout the study, the researchers will collect de-identified data from health insurance billing records to track antibiotic prescribing and the use of diagnostic tests. Doctors and QC moderators will also be invited to complete short online surveys twice a year (10-15 minutes) and may be asked to join optional interviews or group discussions after the winter season. The study will also explore the effectiveness of the implementation strategies on the adoption of the SSI guidelines, as well as the barriers and facilitators to adoption. This study type is known as a hybrid effectiveness implementation study, simultaneously evaluating an intervention's impact on antibiotic prescribing and the strategies used to implement the new national guidelines in a real-world setting. Participation in the study is voluntary. Doctors can withdraw at any time. All data will be handled confidentially and in line with Swiss data protection laws. The study is funded by the Swiss National Science Foundation. No support is received from pharmaceutical companies or manufacturers of diagnostic tests.

Conditions

Acute Respiratory Infection; Influenza-like Illness

Keywords

family medicine; primary care; implementation; hybrid design; effectiveness-implementation study; general medicine; outpatient; antibiotics; antibiotic prescribing; antimicrobial resistance; antimicrobial stewardship; guidelines; shared decision making; CRP; c-reactive protein

Outcome Measures

Primary Outcomes (2)

• Defined daily doses of antibiotics commonly used for acute respiratory infections per 1000 consultations

  Defined daily doses (DDD) of selected antibiotics (amoxicillin, co-amoxicillin, clarithromycin, azithromycin) per 1000 consultations, based on de-identified health insurance billing data. These antibiotics represent those most commonly prescribed for pneumonia, acute bronchitis, and upper respiratory tract infections (excluding pharyngitis, sinusitis, and otitis media).

  Over the influenza-like illness (ILI) season (6 months).

• Penetration of acute respiratory infection guidelines

  Percentage of physicians who self-declare adoption of the new acute respiratory infection (ARI) guidelines (i.e., treating patients according to the guidelines).

  Baseline and after 6 months.

Secondary Outcomes (26)

• Monthly antibiotic prescribing rate

  Monthly for 12 months.

• Model-estimated differences in antibiotic use

  Over the ILI season (6 months).

• Model-estimated differences in antibiotic use

  Over 12 months.

• Use of diagnostic tests

  Over the ILI season (6 months).

• Perceived acceptability of the CRP flowchart

  Baseline and after 6 months.

Other Outcomes (2)

• Knowledge about acute respiratory infection management

  Baseline and after 6 months.

• Cost-effectiveness of ARI guideline implementation

  Over the ILI season (6 months).

Study Arms (2)

Acute respiratory infection guideline implementation

EXPERIMENTAL

Quality circles (QC) and walk-in clinics randomized to the intervention arm will receive an overarching multifaceted implementation strategy for the new acute respiratory infection (ARI) guidelines. This includes educational materials to help the QC moderators or the person responsible for education in the clinic to lead a thematic session in autumn 2025, focusing on the use of a syndromic approach, targeted C-reactive protein (CRP) testing when bacterial infection is suspected, and shared decision-making with patients. Other facets include an information sheet and pocket card for physicians, and patient leaflets on acute cough.

Behavioral: Training Session on acute respiratory infection guideline within a multifaceted implementation strategy

Usual care

NO INTERVENTION

QCs and walk-in clinics randomized to the control arm will continue their routine activities without receiving the educational materials on the new guidelines during the initial phase. In the summer 2026, these groups will be offered the same training materials provided to the intervention arm, with the option to use them in their QC sessions or internal training.

Interventions

Training Session on acute respiratory infection guideline within a multifaceted implementation strategy BEHAVIORAL

Implementation strategies are deployed within quality circles, consisting of a structured educational session including a PowerPoint presentation, a facilitation guide, clinical vignettes, and printed materials for physicians and patients. The session is designed to support clinical decision-making about antibiotic use for ARI, based on targeted use of CRP and shared decision-making.

Acute respiratory infection guideline implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in a study mainly conducted in French
• Agreeing to participate in evaluation surveys

You may not qualify if:

• \- Not having any physician included in the study
• The clinic offers general practice/primary care medicine consultations, including emergencies
• The clinic includes at least five physicians
• The clinic has an "Admission to practice charged to Swiss compulsory health insurance"
• The clinic plans to still be active in April 2026
• Located in one of the following cantons: Vaud, Geneva, Valais, Fribourg, Jura, Neuchatel, Bern, Ticino.
• Serving mainly adult patients
• Willing to participate in the study
• Registered primary care physicians
• Specialist title in general internal medicine or practicing physician.
• Practicing in one of the following cantons: Vaud, Geneva, Valais, Fribourg, Jura, Neuchatel, Bern, Ticino.
• Participating in a QC or working in an outpatient clinic participating in the study\*.
• Willing to participate in a study mainly conducted in French.
• Agreeing to participate in evaluation surveys and agreeing to be invited to interviews
• Eligibility criteria for physicians in clinics :

Sponsors & Collaborators

• Anresis, Swiss Centre for Antibiotic Resistance, University of Bern, Switzerland: collaborator
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• University of Zurich, Institute for Implementation Science in Health care: collaborator
• CHUV, Lausanne University Hospitals, Switzerland: collaborator
• Swiss Pharmacy Association, pharmaSuisse: collaborator

Study Sites (1)

Unisanté

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• Wolfensberger A, Gendolla SC, Dunaiceva J, Pluss-Suard C, Niquille A, Nicolet A, Marti J, Powell BJ, Naef R, Boillat-Blanco N, Mueller Y, Clack L. Systematic method for developing tailored strategies for implementing point-of-care procalcitonin testing to guide antibiotic prescribing in Swiss primary care: a protocol for a mixed-methods participatory approach. BMJ Open. 2025 Mar 5;15(3):e091285. doi: 10.1136/bmjopen-2024-091285.

  PMID: 40044189 BACKGROUND

Related Links

• Description of the study on Unisanté webpage that includes the information sheet for study participants
• Description of the project on the website of Swiss National Science Foundation

Study Officials

• Yolanda Mueller, MD, PhD

  Unisanté, Centre for Primary care and Public Health & University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jelena Dunaiceva, MPH

CONTACT

+41 78 654 23 74; jelena.dunaiceva@unisante.ch; imppro@unisante.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: February 9, 2026
• Study Start: May 19, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data (IPD) from physician questionnaires (excluding free-text responses) will be available via the Unisanté open-access repository starting approximately 12 months after the final data collection (estimated for mid-2027). Data will remain accessible for at least 10 years, after which it will be evaluated for long-term archiving.
• Access Criteria: Any researcher will be able to access the non-identifiable IPD from physician questionnaires (excluding free-text) and related documentation via the Unisanté open-data repository. Data will be shared in open and original formats (.csv and others) under a CC-BY license. All other data, including interview materials and SASIS datasets, will not be shared due to confidentiality requirements or legal restrictions.

Locations

CH (1)